MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0635
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Revision surgery due to a periprosthetic fracture around the stem was performed.During the revision surgery, at the surgeon's discretion, the stem was preserved and only the head was replaced.The fracture was fixed with a plate.
Event or Problem Description
Revision surgery due to a periprosthetic fracture around the stem was performed.During the revision surgery, at the surgeon's discretion, the stem was preserved and only the head was replaced.The fracture was fixed with a plate.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient had a primary total hip arthroplasty since i was able to see a radiograph with the implant in place with the periprosthetic fracture.I can indirectly confirm the revision since i was able to see original stryker stickers indicating the revision implants.However i do not have confirmation such as a post revision x-ray or an operation note or doctors notes.The root cause of this event cannot be determined with certainty since i do not have a timeline nor do i have any pertinent history.Causes of periprosthetic fracture are multifactorial including surgical technique with possible unrecognized non displaced fracture which subsequently displaces, patient factors such as activity level, bmi, and the possibility of trauma.With the information supplied, i would not assign any causality to the implant itself" -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to periprosthetic femoral fracture.The event was confirmed by clinician review of the provided x-ray images: a review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient had a primary total hip arthroplasty since i was able to see a radiograph with the implant in place with the periprosthetic fracture.I can indirectly confirm the revision since i was able to see original stryker stickers indicating the revision implants.However i do not have confirmation such as a post revision x-ray or an operation note or doctors notes.The root cause of this event cannot be determined with certainty since i do not have a timeline nor do i have any pertinent history.Causes of periprosthetic fracture are multifactorial including surgical technique with possible unrecognized nondisplaced fracture which subsequently displaces, patient factors such as activity level, bmi, and the possibility of trauma.With the information supplied, i would not assign any causality to the implant itself".No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 6 ACCOLADE II 127 DEG
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18922061
• Report Number: 0002249697-2024-00439
• Device Sequence Number: 7598674
• Product Code: LPH
• UDI-Device Identifier: 04546540669513
• UDI-Public: 04546540669513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 6721-0635
• Device Lot Number: 57912507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 07/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian